Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
30
Countries
1
Sites
1
Type 2 diabetes
Key facts
- Sponsor
- Novo Nordisk A/S
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 21 Feb 2024 → 14 Apr 2025
- Decision date (initial)
- 2024-02-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-505012-38-00
- WHO UTN
- U1111-1285-1665
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Type 2 diabetes
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10045242 | Type II diabetes mellitus | 10027433 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novo Nordisk A/S
- Sponsor organisation
- Novo Nordisk A/S
- Address
- Novo Alle 1
- City
- Bagsvaerd
- Postcode
- 2880
- Country
- Denmark
Scientific contact point
- Organisation
- Novo Nordisk A/S
- Contact name
- EU Submission Hub
Public contact point
- Organisation
- Novo Nordisk A/S
- Contact name
- EU Submission Hub
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2024-02-21 | 2025-04-14 | 2024-02-26 | 2024-12-19 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-04 | Austria | Acceptable 2024-02-05
|
2024-02-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-13 | Austria | Acceptable 2024-04-29
|
2024-05-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-11 | Austria | Acceptable 2024-07-29
|
2024-08-05 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-12 | Austria | Acceptable 2024-07-29
|
2024-08-12 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-17 | Austria | Acceptable | 2024-11-04 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-17 | Austria | Acceptable 2025-02-17
|
2025-02-23 |